Senior Manager, Medical Writing - Innovative Medicine R&D (Remote, East Coast, USA)

Tevapharm; Macon (NH, GA); Remote; USD 121,000 - 159,000; Full time

Job summary

An established industry player is seeking a Senior Manager in Global Regulatory Medical Writing to lead the production of high-quality clinical documents essential for drug development. This role involves writing and editing regulatory documents, ensuring compliance with guidelines, and providing strategic oversight to teams. Join a mission-driven organization committed to improving health accessibility worldwide, where your expertise will directly impact the lives of millions. If you are passionate about regulatory writing and thrive in a collaborative environment, this opportunity is for you.

Benefits

Comprehensive Health Insurance

401(k) with Employer Match

Paid Time Off

Life and Disability Protection

Tuition Assistance

Employee Stock Purchase Plan

Flexible Spending Accounts

Paid Parental Leave

Virtual Physical Therapy

Identity Theft Protection

Qualifications

• PhD or PharmD in Life Sciences with 4+ years experience or Master's with 6+ years.
• Proficient in regulatory medical writing and document preparation.

Responsibilities

• Write and edit clinical regulatory documents for drug development.
• Provide oversight and resource management for document production.

Skills

Regulatory Medical Writing

Microsoft Word

Scientific Messaging

Document Preparation

English Proficiency

Education

PhD in Life Sciences

Master's in Life Sciences

Tools

Document Templates

Job description

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Senior Manager, Medical Writing - Innovative Medicine R&D (Remote, East Coast, USA)

Date: May 4, 2025

Location:

Macon, United States, New Hampshire, 10903

Job Id: 59605

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

As a Senior Manager in Global Regulatory Medical Writing, you will write and edit clinical regulatory documents, including submission summaries and other complex materials essential for drug development and product registrations. You will provide intermediate-level oversight, guidance, and resource management to ensure the effective production of high-quality clinical research documentation.

How you’ll spend your day

• Focus on product and program-level responsibilities, providing leadership and accountability for key regulatory documents.
• Potentially oversee direct reports, contingent workers, and/or vendors, while also offering training and resource management support.
• Provide strategic supervision, leadership, and planning for the development of clinical regulatory documents.
• Write and edit various types of clinical regulatory documents, ensuring content is accurate, complete, and adheres to regulatory guidelines and editorial standards.
• Ensure documents are clear, consistent, and align with regulatory medical writing best practices, including appropriate context and scientific messaging.
• Contribute to the preparation and revision of document templates, enhancing process efficiency and quality.

Your experience and qualifications

• PhD or PharmD in Life Sciences (or related field) with a minimum of 4 years of experience, or a Master’s degree in Life Sciences (or related field) with at least 6 years of experience.
• Preferred experience: 4-6 years in regulatory medical writing.
• Proficient in Microsoft (MS) Word and adept at using software, templates, and electronic formats for document preparation.
• Recognized as a competent manager with advanced expertise in regulatory medical writing.
• Skilled in writing and editing various types of clinical regulatory documents, ensuring clarity, accuracy, and compliance with regulatory guidelines.
• Advanced understanding of global regulations and guidelines for document submissions, therapeutic areas, statistical concepts, and product development.
• Strong English language proficiency, both written and spoken.

Compensation

The annual starting salary for this position is between $121,000 - 159,000. Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.

This position may also be eligible for bonus. Level of the role will be commensurate to years of experience and performance criteria.

RELOCATION ASSISTANCE AND WORK VISA SPONSORSHIP IS NOT AVAILABLE

Enjoy a more rewarding choice

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

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